BEUDAMED
    FDA Adverse Event Summary report: N

    MBA HEMOSTASIS VALVE

    MDR report key: 14103154 · Received April 12, 2022

    Report

    Report Number
    MW5108933
    Date Received
    April 12, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 8, 2022
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DEVICE SHOULD ALLOW THE ARTERIAL PRESSURE TO BE CONTINUOUSLY MONITORED THROUGH THE GUIDING CATHETER. ARTERIAL PRESSURE READINGS ARE FREQUENTLY DAMPENED WHILE USING THIS DEVICE. THIS IS RAISING SAFETY CONCERNS BECAUSE PHYSICIANS RELY ON THE PRESSURE WAVEFORMS TO INDICATE THAT THEY ARE NOT OBSTRUCTING BLOOD FLOW IN THE CORONARY ARTERY. SINCE THE WAVEFORMS ARE FREQUENTLY DAMPENED WITH THIS DEVICE, THE PHYSICIANS ARE CONCERNED THAT THEY ARE PERFORMING PROCEDURES IN A LESS SAFE ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787966 MBA HEMOSTASIS VALVE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS DTL MERIT MEDICAL SYSTEMS, INC. K2337333

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male